61
Participants
Start Date
September 15, 2017
Primary Completion Date
September 28, 2019
Study Completion Date
September 28, 2019
Group A- Tofacitinib
Group A patients will receive Tofacitinib 5mg BD. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 10 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response.
Group B- Methotrexate
Group B patients will receive Methotrexate in increasing dose weekly with maximum dose up to 25 mg/week. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to highest dose of MTX at the end of 3 months will be put on Tofacitinib 5 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response.
Bangabandhu Sheikh Mujib Medical University, Dhaka
Lead Sponsor
Globe Pharmaceuticals Limited
OTHER